Corporate Banner
Satellite Banner
ADME Tox
Scientific Community
 
Become a Member | Sign in
Home>Events>This Event
  Events - July 2013


Pharmacokinetics in Drug Development - for the Non-Specialist

01 Jul 2013 - 02 Jul 2013 - London, UK



Bookmark and Share


In drug development clinical pharmacology is tasked to ensure that patients receive the right dose at the right time. This ensures that the new medicine is safe and effective throughout the patient population. To achieve this goal, it is necessary to recognise the factors that can alter drug response. Knowledge of pharmacokinetics (PK) and pharmacokinetic/pharmacodynamic (PK/PD) relationships is at the heart of this endeavour. For many drugs, clinical pharmacology information accounts for almost 50% of the final drug label, further emphasising the importance of PK understanding in drug development.

Course Objectives

To provide participants with an overview of the principles of Pharmacokinetics and Pharmacokinetic/Pharmacodynamic modelling and how, together with regulatory guidances, they can be used to effectively deliver drug development programmes

What will participants gain-

  • Increased confidence to discuss PK issues within their drug projects
  • Understanding of the common PK terms and their importance
  • Understanding of how PK data influences the clinical development programme
  • An understanding of the factors that contribute to variability in PK
  • The role of PK/PD modelling in drug development
  • An appreciation of how regulatory guidances influence PK

Who Should Attend?

The course is intended for all professionals in the drug development arena especially those that work in or with clinical project teams (eg Regulatory Affairs specialists; Medical personnel; Project managers/leaders; Clinical research associates, Medical writers) who want to further their knowledge of the usefulness of PK in their projects.

Numbers are restricted for maximum benefit to participants

Course Programme

Course will commence with registration at 8.30am, course proper at 9.00am and will finish at 5.00pm each day.

Day 1: Pharmacokinetic Principles

The principle processes involved in PK will be discussed and the jargon used in their description and quantification will be explained.

What is PK and why is it important

  • Absorption, distribution, metabolism and elimination
  • Therapeutic windows
  • PK terminology
  • Clearance, Volume of distribution

PK techniques

  • Non compartmental Analysis
  • Compartmental modelling
  • PK/PD modelling
  • Regulatory environment
  • Data interpretation
  • Reporting

Day 2: PK in Drug Development

The application of PK in clinical development will be addressed by looking at questions that commonly arise within drug projects. Examples include: "What are the implications of pre-clinical PK findings on the design of early phase development studies"; "How is the clinical relevance of a drug drug interaction assessed" and "What are the sources of variability in pharmacokinetic response".

Early phase development

  • Dose choice in first in human studies
  • Drug interactions; CYPs and transporters, strategies and regulatory guidance; types of interaction competitive vs mechanism based; co-medication strategy for patient studies
  • Radiolabel studies to assess routes of elimination
  • Assessing bioequivalence (oral and inhaled routes)

Variability in PK

  • Genetic polymorphisms
  • Influence of age
  • Food effects

Several "learning in action" workshops during both days will provide participants with the opportunity to apply knowledge gained during the lectures.

Participants will need to bring along a scientific calculator



Further information
Scientific News
The Rise of 3D Cell Culture and in vitro Model Systems for Drug Discovery and Toxicology
An overview of the current technology and the challenges and benefits over 2D cell culture models plus some of the latest advances relating to human health research.
Breakthrough Approach to Breast Cancer Treatment
Scripps scientists have designed a drug candidate that decreases growth of breast cancer cells.
Non-Toxic Approach to Treating Variety of Cancers
A team of researchers at Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine recently discovered a novel, non-toxic approach to treating a wide variety of cancers.
Making Injectable Medicine Safer
Researchers remove excess additives from drugs, which could reduce the odds of serious allergic reactions and other side effects.
An Old-New Weapon Against Emerging Chikungunya Virus
Researchers utilize existing drugs to interfere with host factors required for replication of Chikungunya virus.
Brazilian Zika Virus Strain Causes Birth Defects in Experimental Models
First direct experimental proof of causal effect, researchers say.
'Kidney on a Chip' Facilitates Safer Drug Dosing
University of Michigan researchers have used a "kidney on a chip" device to mimic the flow of medication through human kidneys and measure its effect on kidney cells.
Ketamine Metabolism Lifts Depression
NIH-funded team finds rapid-acting, non-addicting agent in mouse study.
Turning Skin Cells into Heart, Brain Cells
In a major breakthrough, scientists at the Gladstone Institutes transformed skin cells into heart cells and brain cells using a combination of chemicals.
Growing Stem Cells More Safely
Nurturing stem cells atop a bed of mouse cells works well, but is a non-starter for transplants to patients – Brown University scientists are developing a synthetic bed instead.
Scroll Up
Scroll Down
SELECTBIO

SELECTBIO Market Reports
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,100+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,500+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!